First MS-MLPA assay CE-marked: ME011 Mismatch Repair Genes

MRC Holland’s SALSA^® MLPA^® Probemix ME011 Mismatch Repair Genes is the first methylation-specific (MS) MLPA probemix to be CE-marked for in vitro diagnostic use in Europe*. ME011 is used to determine both copy number changes and the methylation status of selected promoter regions of the MLH1, MSH2, PMS2 and MSH6 genes. These genes are associated with the cancer-predisposing Lynch syndrome. In addition, the assay can be used to detect the common BRAF p.V600E mutation, and deletions or duplications in the 3' region of the EPCAM gene. Sample DNA derived from both peripheral blood and from fresh, frozen, or FFPE tissue is compatible with this assay**.

* EU (candidate) member states and members of the European Free Trade Association (EFTA).

** See the ME011 Product Description for details.